None listed
Conditions
Brief summary
A Randomized Controlled Trial to investigate photobiomodulation as adjunctive to rehabilitation exercise in knee osteoarthritis in Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Malaysia. This study is to provide new insights into the long-term disease-modifying effects of high intensity laser therapy as a supplement to rehabilitative activities for individuals with mild-to-moderate knee osteoarthritis. The research hypothesis is combining high intensity laser therapy with rehabilitation exercise will significantly reduce knee pain, improve physical function, and reduce knee-related disability levels among adults with mild to moderate knee osteoarthritis in the long term.
Interventions
This study included both groups: the exposed group (HILT+E); the comparison group (PL+E)
Both groups will receive HILT (BTL-6000: 5 W, 1064 nm, 19 to 150 J/cm2, and 3190 J per session) and sham laser (without emission of energy) as an adjunctive treatment, respectively, in addition to knee rehabilitation exercise (standard physiotherapy care). The same intensity and frequency will be applied for whole session. The laser will be applied on anterior knee for 15 minutes each session. The participa
This study included both groups: the exposed group (HILT+E); the comparison group (PL+E) Both groups will receive HILT (BTL-6000: 5 W, 1064 nm, 19 to 150 J/cm2, and 3190 J per session) and sham laser (without emission of energy) as an adjunctive treatment, respectively, in addition to knee rehabilitation exercise (standard physiotherapy care). The same intensity and frequency will be applied for whole session. The laser will be applied on anterior knee for 15 minutes each session. The participants will received one treatment per week for twelve consecutive weeks. The mode of administration will be one-on-one consultation and the participants will be reminded one day before the appointment by phone call. Both groups participants will engage in exercises based on specific KOA guidelines, with each exercise tailored to their needs, considered there is no difference between both groups.
Sponsors
Geran Galakan Penyelidik Muda (GGPM),under Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i. Adults aged 18 years and above of both sexes. ii. Individuals diagnosed with unilateral or bilateral KOA by an orthopaedic doctor. iii. Those with a Kellgren-Lawrence classification of mild to moderate KOA based on a knee radiograph conducted within the last six months iv. Individuals capable of engaging in the intervention and assessment program without restrictions. In cases where both knee joints are affected, the knee with more severe symptoms, based on the pain score, will be included. If symptoms are identical in both knees, the dominant knee will be assessed.
Exclusion criteria
i. Presence of other pathological conditions like rheumatic disease, prior hip or knee joint replacement, congenital dysplasia, osteochondritis dissecans, intra-articular fractures, septic arthritis, ligament or meniscus injury, and any other condition impeding the healing process, including diabetes mellitus and peripheral vascular disease ii. comorbidities hindering physical evaluation iii. ongoing participation in another KOA-related interventional study iv. individuals taking prescription glucosamine sulfate, which might potentially affect the study's outcomes. v. Participants who had undergone intra-articular knee injections (e.g., corticosteroid, hyaluronic acid, or blood-derived products) for KOA management in the last six months
Outcome results
None listed